RAPIDSCREEN RS-2000D AND RS-DIGITAL
Received May 18, 2006
Report 3005156333-2006-00001 · MDR key 716559
Device
Generic name
Computer Aided Detection System (cad)
Manufacturer
Riverain MedicalModel number
NACatalog number
NA
Lot number
NA
Product problems
- Computer Software Problem
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
ON APRIL 24, 2006, A CONTROL FILE ERROR WITH RESPECT TO THE RAPIDSCREEN RS-2000D AND RS-DIGITAL DEVICE WAS DISCOVERED DURING A CLINICAL STUDY BEING CONDUCTED FOR A PMA SUPPLEMENTAL SUBMISSION. THE CONTROL FILE ERROR RESULTS IN SENSITIVITY AND SPECIFICITY THAT DIFFER FROM THE PMA-APPROVED PRODUCT SPECIFICATIONS FOR THE DEVICE. SPECIFICALLY, THE PRODUCT THAT WAS PLACED INTO COMMERCIAL DISTRIBUTION HAS A SENSITIVITY OF 57% AND A SPECIFICITY OF 3.97 (FALSE POSITIVES PER IMAGE), WHICH DIFFERS FROM THE FDA-APPROVED PRODUCT, WHICH HAS A SENSITIVITY OF 63.3% AND A SPECIFICITY OF 5.0. THUS, THERE IS A DIFFERENCE OF 6.3% IN SENSITIVITY AND OF 1.03 IN SPECIFICITY.
Remedial action
- Recall